Status:
UNKNOWN
Evaluation of the Modified Atkins Diet in Children With Epileptic Spasms
Lead Sponsor:
Lady Hardinge Medical College
Conditions:
Epileptic Spasms
Eligibility:
All Genders
9-3 years
Phase:
PHASE2
PHASE3
Brief Summary
Epileptic spasms are a difficult to treat epileptic condition in young children. The first line treatment is hormonal treatment, in the form of ACTH or oral steroids, which are effective in 60-70% of ...
Detailed Description
Epileptic spasms comprise an infantile epileptic encephalopathy characterized by hypsarrhythmia on EEG, and frequent neurodevelopmental regression. Unfortunately the treatment of this disorder remains...
Eligibility Criteria
Inclusion
- Age 9 months to 3 years
- Presence of epileptic spasms in clusters in child 9 months to \<3years of age, with electroencephalographic evidence of hypsarrhythmia or its variants, persisting, at least one cluster per day, despite treatment with either oral corticosteroids or adrenocorticotrophic hormone (ACTH) and one additional anticonvulsant (valproate/ benzodiazepine/ vigabatrin/ topiramate/ zonisamide/ levetiracetam) for at least 4 weeks.
Exclusion
- Children with known or suspected inborn error of metabolism
- Children with renal, pulmonary, cardiac or hepatic dysfunction
- Severe malnutrition (weight for length or weight for height less than -3 Z score as per WHO growth charts)
- Motivational or psychosocial issues in the family which might affect the compliance
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03807141
Start Date
January 15 2019
End Date
March 31 2022
Last Update
February 5 2019
Active Locations (1)
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1
Lady Hardinge Medical College
New Delhi, National Capital Territory of Delhi, India, 110018